Calquence 100 mg Acalabrutinib Film-Coated Tablets – 60 Tablets

Calquence 100 mg Acalabrutinib Film-Coated Tablets – 60 Tablets

Calquence 100 mg (Acalabrutinib) is a prescription targeted cancer medicine used to treat certain B-cell malignancies in adults.

It belongs to a class of medicines known as Bruton's tyrosine kinase (BTK) inhibitors, which block signaling pathways involved in the growth and survival of malignant B cells.

Calquence is used for chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). It may also be used for mantle cell lymphoma (MCL) in specific patient populations, depending on locally approved indications and treatment protocols.

By inhibiting BTK activity, Calquence helps reduce cancer-related signaling and delay disease progression in eligible patients.

Calquence may be prescribed alone or in combination with other cancer treatments, depending on the diagnosis and treatment plan.

Pack Contents: 60 film-coated tablets, each containing 100 mg of acalabrutinib.

Active Ingredient & Strength

Acalabrutinib

Acalabrutinib is a BTK inhibitor that blocks a key enzyme involved in B-cell receptor signaling.

Therapeutic Benefits:

• Inhibit BTK activity.
• Reduce malignant B-cell growth signaling.
• Help slow progression of selected blood cancers.
• Support disease control in eligible patients.
• Provide a targeted treatment option used alone or in combination regimens.

Strength: 100 mg per film-coated tablet.

Therapeutic Indications

1. Chronic Lymphocytic Leukemia (CLL)

Calquence is used to treat adults with chronic lymphocytic leukemia, a blood cancer involving abnormal B lymphocytes.

Treatment may help:

• Inhibit malignant cell signaling.
• Delay disease progression.
• Improve disease control.
• Support longer progression-free survival in selected patients.

2. Small Lymphocytic Lymphoma (SLL)

Calquence is also used to treat small lymphocytic lymphoma, a closely related condition that primarily affects lymph nodes and lymphatic tissues.

3. Mantle Cell Lymphoma (MCL)

Calquence may be used for certain patients with mantle cell lymphoma, including selected previously treated patients or patients receiving approved combination regimens.

Important: Approved MCL indications may differ between countries. The locally approved prescribing information should be checked before publishing this indication for Saudi Arabia.

How It Works

BTK is an important enzyme involved in signaling through B-cell receptors.

These signals contribute to the growth, survival and activity of normal and malignant B cells.

Acalabrutinib inhibits BTK, reducing signaling pathways that support the survival and proliferation of certain cancer cells.

Calquence is a targeted therapy, not traditional cytotoxic chemotherapy.

Dosage & Administration

Usual Dose for Several Approved Indications: 100 mg twice daily, approximately 12 hours apart.

• Take orally.
• May be taken with or without food.
• Swallow tablets whole with water.
• Do not crush, split or chew tablets.
• Take at approximately the same times each day.
• May be prescribed alone or with other cancer treatments.
• Dose adjustments may be required for adverse effects or drug interactions.
• Do not discontinue or change the dose without medical advice.

Missed Dose

If a dose is missed by less than 3 hours, take it when remembered.

If more than 3 hours have passed since the scheduled dose, skip the missed dose and take the next dose at the usual time.

Do not double the dose.

Monitoring Requirements

Regular monitoring may include:

• Complete Blood Count: To monitor blood cells and platelets.
• Infection Assessment: Due to the risk of serious infections.
• Bleeding Assessment: To detect abnormal bleeding or bruising.
• Liver Function: When clinically indicated.
• Cardiac Monitoring: Particularly in patients at risk of arrhythmias.
• Treatment Response: Through blood tests, examinations and imaging.
• Medication Review: To identify potential interactions.

Possible Side Effects

• Headache.
• Diarrhea.
• Fatigue.
• Muscle and joint pain.
• Bruising.
• Respiratory infections.
• Nausea.
• Low blood cell counts.
• Skin rash.

Serious Adverse Effects

Potential serious risks include:

• Major bleeding.
• Serious infections.
• Severe cytopenias.
• Cardiac arrhythmias, including atrial fibrillation.
• Second primary malignancies, including skin cancers.
• Drug-related liver injury in some patients.

Seek urgent medical attention for uncontrolled bleeding, black stools, vomiting blood, high fever, or palpitations accompanied by dizziness or fainting.

Warnings & Precautions

• Prescription-only medicine.
• Use under hematology or oncology specialist supervision.
• May increase bleeding risk.
• Caution is required with anticoagulants and antiplatelet medicines.
• Serious or opportunistic infections may occur.
• May cause low blood cell counts.
• May cause cardiac arrhythmias.
• Inform the physician about any history of heart disease.
• Temporary interruption may be necessary before surgery or dental procedures.
• Monitor for unusual skin changes.
• May cause fetal harm; pregnancy should be avoided during treatment.
• Follow approved contraception recommendations.
• Avoid breastfeeding during treatment and for 2 weeks after the final dose.
• Inform the healthcare team about all medicines and supplements.
• Do not adjust treatment independently.

Drug Interactions

Calquence may interact with medicines that affect CYP3A activity.

Examples include:

• Certain antifungals such as ketoconazole and itraconazole.
• Certain antibiotics such as clarithromycin.
• Rifampicin.
• Some antiseizure medicines such as carbamazepine and phenytoin.
• Anticoagulants and antiplatelet medicines.
• St. John's wort.

Important: Calquence film-coated tablets have different absorption characteristics from the older capsule formulation. Acid-reducing medicine interaction guidance should be based on the specific tablet formulation rather than capsule instructions.

Storage

• Store according to the approved packaging instructions, generally at 20°C–25°C.
• Protect from excessive heat and moisture.
• Keep in the original packaging.
• Keep out of reach of children.

Frequently Asked Questions

What is Calquence 100 mg used for?

It treats certain B-cell cancers, including chronic lymphocytic leukemia and small lymphocytic lymphoma.

What is the active ingredient in Calquence?

Acalabrutinib.

Is Calquence chemotherapy?

No. It is a targeted BTK inhibitor.

What is the usual Calquence dose?

100 mg twice daily for several approved indications, unless otherwise directed by the specialist.

Can Calquence be taken with food?

Yes. It may be taken with or without food.

Can Calquence cause bleeding?

Yes. It may increase bleeding risk, so unusual bruising or bleeding should be reported.

Does Calquence affect the immune system?

It may increase infection risk in some patients.

Can Calquence cause headaches?

Yes. Headache is a recognized adverse effect.

Can Calquence cause irregular heartbeat?

Cardiac arrhythmias may occur in some patients.

Can Calquence be taken with acid-reducing medicines?

Interaction guidance depends on the formulation. Film-coated tablets differ from capsules, so consult the prescribing information.

Can Calquence be stopped when blood tests improve?

Do not discontinue treatment without specialist advice.

How many tablets are included?

60 film-coated tablets containing 100 mg each.

How long does a 60-tablet pack last?

At the usual dose of one tablet twice daily, one pack lasts 30 days.

Product Details

• Brand Name: Calquence
• Active Ingredient: Acalabrutinib
• Strength: 100 mg per Tablet
• Pack Size: 60 Tablets
• Dosage Form: Film-Coated Tablets
• Drug Class: Bruton's Tyrosine Kinase (BTK) Inhibitor
• Indications: Selected B-Cell Malignancies, Including CLL and SLL
• Usual Dose: 100 mg Twice Daily for Several Indications
• Tablets per Usual Daily Dose: 2 Tablets
• Pack Duration at Usual Dose: 30 Days
• Route of Administration: Oral
• Manufacturer: AstraZeneca
• Storage: Room Temperature According to Packaging Instructions
• Prescription Status: Prescription Only
• Category: Oncology & Hematology Medications